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AM-101 in the Treatment of Post-Acute Tinnitus 1 (AMPACT1)

This study has been completed.
Information provided by (Responsible Party):
Auris Medical, Inc. Identifier:
First received: August 15, 2013
Last updated: January 26, 2017
Last verified: January 2017
The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.

Condition Intervention Phase
Drug: AM-101
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) - an Open-Label Extension to the TACTT2 Study

Resource links provided by NLM:

Further study details as provided by Auris Medical, Inc.:

Primary Outcome Measures:
  • Hearing threshold [ Time Frame: Up to Day 203 ]
    Occurrence of deterioration in hearing threshold in the treated ear(s)

Secondary Outcome Measures:
  • Hearing threshold [ Time Frame: Up to Day 252 ]
    Difference and occurence of deterioration of hearing threshold in the treated ear(s)

  • Adverse events and serious adverse events [ Time Frame: Throughout subject study participation ]
    Occurrence and severity of adverse events and serious adverse events

Enrollment: 260
Study Start Date: June 2014
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AM-101 injection
AM-101 gel for intratympanic injection
Drug: AM-101
AM-101 gel for intratympanic injection

Detailed Description:
This open-label extension study is assessing the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).

Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Completion of TACTT2 study;
  • Negative pregnancy test (woman of childbearing potential);
  • Willing and able to attend the study visits during at least one treatment cycle.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Adverse event leading to treatment discontinuation in TACTT2;
  • Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
  • Ongoing drug-based therapy for otitis media or otitis externa;
  • Drug-based therapy known as potentially tinnitus-inducing;
  • Other treatment of tinnitus;
  • Drug abuse or alcoholism;
  • Subjects with psychiatric diseases requiring drug treatment;
  • Use of antidepressant or anti-anxiety medication;
  • Any clinically relevant disorder or abnormality in physical examination;
  • Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
  • Women of childbearing potential who are unwilling or unable to practice contraception.

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01934010

United States, Ohio
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Auris Medical, Inc.
  More Information

Responsible Party: Auris Medical, Inc. Identifier: NCT01934010     History of Changes
Other Study ID Numbers: AM-101-CL-12-03
Study First Received: August 15, 2013
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 22, 2017